Timely, accurate, reliable and pervasive communication with physicians and patients is required for patient protection and safety, and for national defense against biological or communicable threats. But despite advancements in information and communication technology, most direct outreach to physicians and patients related to patient safety, product warnings or public health issues continue to rely on broadcast media and U.S. mail. Over 250 times each year, manufacturers, federal agencies and other third parties outreach directly to physicians, principally using the U.S. mail. Most of these messages relate not only to physicians themselves, but also directly to the patients in their care. These physicians, however, have no practical means by which to outreach to their patients and share the information, warnings, recalls or patient safety messages. In addition, mail-based physician outreach has inconsistent results and poor documentation.
Communicating efficiently and effectively with physicians and patients is critical to ensure patient and public safety. Manufacturers of healthcare products and services are at times required to contact physicians with information regarding their products and services. The information may be a product recall, warning, or other information of importance. In 2003 alone, there were a combined total of over 50 Class 1 FDA-mandated medication and device recalls, nearly all of which required direct notification of large numbers, typically hundreds of thousands, of physicians. In March 2004, over 100 medications had FDA-approved label changes, most related to new contraindications and warnings. Finally, it is estimated that over 25,000 safety reports on clinical trial investigational new drugs (“INDs”) are sent annually. Currently, the principal method for communicating FDA-related product recalls or warnings directly to physicians is the U.S. mail. The current method for communicating FDA-related product recalls or warnings to patients/consumers is through press releases and media, and physician notification of their patients using telephone or U.S. mail.
In addition to FDA-related notifications, federal agencies and other public health advocates such as the Centers for Disease Control (the “CDC”) also have a need to communicate rapidly with physicians in the event of a natural disaster, communicable outbreak, bioterrorism or other similar events. For the most part, current communication to physicians by government agencies related to emergent public safety is via media, fragmented outreach to local health systems, or the US Mail. Federally funded AHRQ studies from 2002 and 2004 demonstrated that while information technology held clear promise as a vehicle for physician communication in the event of emergent public health needs, the current notification systems are fragmented and under-funded, leaving the country and its citizens vulnerable.
As set forth above, there are many circumstances requiring that physicians or other individuals be contacted regarding situations affecting public health and safety. For instance, product recalls, warnings or label changes on medications may affect the health and safety of individuals taking these medications. Other possible scenarios affecting groups of individuals may include attempts at bio-terrorism or local epidemic outbreaks. In these circumstances, it is important to notify the affected individuals in a timely manner. The Federal Drug Administration (FDA) and the Centers for Disease Control (CDC) are among those charged with the responsibility of ensuring that members of the public are notified when these situations arise. Typically, organizations such as the FDA, the CDC, and pharmaceutical companies (among others) communicate with physician practices via U.S. mail. However, there is no way to ensure that the physicians have opened their mail. Moreover, there is generally a significant time delay between the time that mail is sent and the time that mail is received. In fact, after printing and handling, the U.S. mail typically takes several days to reach addressees. Moreover, U.S. mail that is not delivered appropriately often results in no, or delayed, notification to the sender. In some circumstances, Federal Express may be used in urgent situations. However, this option is costly and therefore only done in rare circumstances. Moreover, even with Federal Express, a day can be a significant amount of time when a person's health or safety is involved. In addition, physicians' addresses often change without timely notification. Even when the physician has received the mailed notification, there is no guarantee that the physician will open his or her mail, or that the appropriate patients will be notified by the physician. Unfortunately, there is currently no efficient mechanism in place to enable physicians to notify their patients, often resulting in further notifications to be sent via U.S. mail, if at all.
In conjunction with product recalls, warnings and other similar notifications, the FDA will often mandate that the responsible manufacturer conduct follow up studies to determine the efficacy of the mailing. These studies involve making contact with the physicians to ensure that the letter was received and read, and that the physician then notified his or her patients of the health-related issue addressed in the letter sent to the physician. While it is possible to confirm delivery of U.S. mail, this confirmation is limited to receipt of the mail piece only. Unfortunately, there is no efficient way for such a company to perform this research to ensure that the physician actually received and read the notification, and then took the appropriate measures to ensure that his or her patients were notified.
In addition, the physician may require more information than is typically contained in the notification, and because the notification is paper-based, several more steps are required for the physician to obtain access to this additional information.
It is also important to note that there is currently no mechanism in place for notifying the affected individuals, such as patients of physicians or those who care for them, of the types of developments set forth above, nor is there any way to effect broader outreach to all individuals in a particular area, for example, when a local or regional health crisis occurs. This is also true and becomes even more challenging on a nationwide scale, when notification might be required in the event of a bioterrorism event. For this reason and due to the time delays involved with mailing health-related notifications to physicians, the FDA and the CDC often turn to the media, such as television or radio, to notify the public of emergency or health-related situations. In this manner, the general public may be notified in a more efficient manner. Unfortunately, there is no guarantee that the notifications or warnings will reach the desired individuals. In view of the above, it would be beneficial if a more efficient mechanism for notifying physicians and patients of health-related matters could be implemented.